MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

Status Enrolling by invitation

Clinical Trial Summary

Clinical Trial Description

The objective of this retrospective/prospective consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty, fractures and revision total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7 and 10-year follow-up* to meet EU Medical Device and other regulatory requirements for post market surveillance. Because Comprehensive Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well in order to collect long-term data. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to either implant or instrumentation should be specified. The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs). *The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04003272
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Enrolling by invitation
Phase
Start date	October 28, 2019
Completion date	July 29, 2029

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04930393` - Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients	N/A
Completed	`NCT03717753` - Rotator Cuff Pathway	N/A
Completed	`NCT04454671` - Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment	N/A
Completed	`NCT06274827` - Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises	N/A
Not yet recruiting	`NCT05413213` - Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder	N/A
Not yet recruiting	`NCT05043844` - Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder	N/A
Recruiting	`NCT02903719` - The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection.	Phase 4
Completed	`NCT02777281` - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI	N/A
Completed	`NCT02554968` - Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Recruiting	`NCT02242630` - Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis	N/A
Active, not recruiting	`NCT02843269` - Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM	N/A
Completed	`NCT02631395` - The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball	N/A
Completed	`NCT01885377` - SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain	N/A
Completed	`NCT01733914` - Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain	Phase 2
Completed	`NCT01205542` - Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function	N/A
Completed	`NCT01843660` - An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain	Phase 4
Completed	`NCT00743600` - Ultrasound Evaluation of the Rotator Cable and Associated Structures.	N/A
Completed	`NCT00679887` - Chronic Shoulder Pain Treated by Pressures With the Thumbs on the Trigger Points	Phase 1/Phase 2
Completed	`NCT04058522` - Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection	N/A
Completed	`NCT03353272` - The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain	N/A